ANDA 218830, held by Square Pharms PLC. Methimazole.
As of Nov 13, 2026, ANDA 218830 (Methimazole), held by Square Pharms PLC, was first approved by FDA on Feb 5, 2025, with 0 approved supplements and 0 published complete response letters.
INDICATIONS AND USAGE
| Date | Submission | Status | Documents |
|---|---|---|---|
| Feb 5, 2025 | Original application | Approved | None posted |
| Methimazole5MG · tablet;oral | Methimazole | Rx |
| Methimazole10MG · tablet;oral | Methimazole | Rx |
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters
